Label: FIRST AID ANTIBIOTIC- bacitracin zinc ointment

  • NDC Code(s): 53329-089-01, 53329-089-86, 53329-089-87
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 8, 2023

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  • Active ingredient (in each gram)

    Bacitracin Zinc 500 units, USP

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    • For external use only

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use

    on deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • if a rash or other allergic reaction occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area.
    • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
    • May be covered with a sterile bandage.
  • Other information

    • store at controlled room temperature 68º-77ºF (20º-25ºC)
    • tamper evident, do not use if pack is torn, cut or opened
    • avoid excessive heat and humidity
  • Inactive ingredients

    mineral oil, paraffin, white petrolatum

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of domestic and imported materials

    1-800-633-5463

    REF: CUR110556

    V3 RI22GZP

  • Package Label

    Label V3 RI22GZP

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIBIOTIC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-089-011 in 1 BOX03/01/2010
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53329-089-86144 in 1 CARTON03/01/2010
    2NDC:53329-089-870.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-089-870.9 g in 1 PACKET; Type 0: Not a Combination Product03/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/01/2010
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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